Kataoka 2010.
Methods | Study design: randomised controlled trial Randomisation method: random numbers table Power calculation: none reported Study dates: from February to November 2003 |
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Participants | Setting: antenatal clinic of an urban general hospital Country: Japan Inclusion criteria: women < 25 weeks pregnant Exclusion criteria: none stated Number (%) of eligible recruited: 328/355 (92.4%) Numbers randomised 328: interview 165, questionnaire 163 Numbers analysed (% recruited) at first time point 328: interview 165 (100%), questionnaire 163 (100%) Number of dropouts at second time point: interview 10, questionnaire 3 Numbers analysed (% recruited) at second time point: 315; interview 155 (93.9%), questionnaire 160 (98.2%) Number of dropouts at third time point: interview 7, questionnaire 11 Numbers analysed (% recruited) at third time point: 297; interview 148 (89.7%), questionnaire 149 (91.4%) Age: 20 to 29 years 30.5%, 30 to 39 years 66.2%, ≥ 40 years 3% Marital status: married 96.3%, single 2.1% Education: high school 13.4%, junior college 43.6%, university degree 41.8% Employment: full‐time 33.8%, part‐time 17.7%, not working 46.9% Lifetime experience of physical violence by male partner: 20 (5.8%); interview 8 (4.8%); questionnaire 11 (6.8%) |
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Interventions | Intervention group
Control group
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Outcomes | Primary outcome
Secondary outcomes
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Notes | Funding: Grant‐in‐Aid for COE (Centre of Excellence) Research, provided by the Ministry of Education, Culture, Sports, Science and Technology of Japan | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Researchers "used a random number table in blocks of four to ensure that approximately equal numbers of women were allocated to each group" |
Allocation concealment (selection bias) | Low risk | Although it was indicated that numbered, sealed envelopes were used, it was unclear whether opaque envelopes were used. However, since there was no clear intervention/comparison group, the likelihood that selection bias was introduced is low |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The researchers indicate "because of the nature of the screening methods, participants could not be blinded to the group assignment." However any such bias was likely distributed equally across the 2 groups. Although the extent of the knowledge about participants' assignment, especially given the repeat visits among personnel, is unclear it is unlikely to have influenced the outcomes differentially in the groups |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | There was no blinding of outcome assessment; however, the outcome measurement is not likely to be differentially influenced in the 2 groups by lack of blinding as there was not a clear intervention or comparison group. Also the "same researcher performed the allocation procedure and data analysis" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates were low and balanced in the 2 groups (intervention group 10.3%; control group 8.6%). 2 people in the interview group refused to continue compared to 0 in the questionnaire group |
Selective reporting (reporting bias) | Low risk | Primary and secondary outcomes reported as specified in protocol. The trial was registered (UMIN‐CTRC000000353) |
Other bias | High risk | "Measurements of primary and secondary outcomes had psychometric property limitations" |